Selective Serotonin Reuptake Inhibitor

Escitalopram for Anxiety

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience, Cincinnati, OH
EscitalopramPhase 4RecruitingLed by Laura B Ramsey, PhDResearch Sponsored by University of Cincinnati

Study Summary

This trial will test whether a person's metabolism affects how they respond to the drug escitalopram. 132 people will be given the drug and monitored for 12 weeks.

Eligible Conditions
  • Anxiety

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have been diagnosed with generalized, social, and/or separation anxiety disorder according to specific criteria.
Your overall level of symptoms is rated as moderate to severe by the doctor during two visits.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12/early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12/early termination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pediatric Anxiety Rating Scale severity score
Secondary outcome measures

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
Tension/Inner Unrest
Reduced Salivation
Concentration Difficulties
Diminished Sexual Drive
Asthenia/Lassitude/Increased Fatigability
Orthostatic Dizziness
Erectile Dysfunction
Failing Memory
Increased Duration of Sleep
Reduced Duration of Sleep
Increased Dream Activity
Accomodation Disturbance
Increased Tendancy to Sweating
Weight Gain
Ejaculatory Dysfunction
Micturtion Disturbances
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard dosingExperimental Treatment1 Intervention
Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.
Group II: Pharmacogenetically-guided escitalopram dosingExperimental Treatment1 Intervention
Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a site

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,903 Previous Clinical Trials
2,198,823 Total Patients Enrolled
7 Trials studying Anxiety
4,794 Patients Enrolled for Anxiety
University of CincinnatiLead Sponsor
401 Previous Clinical Trials
621,502 Total Patients Enrolled
6 Trials studying Anxiety
692 Patients Enrolled for Anxiety
Laura B Ramsey, PhDPrincipal Investigator
Children's Mercy Kansas City
Jeffrey R Strawn, MDPrincipal Investigator
University of Cincinnati
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Anxiety
60 Patients Enrolled for Anxiety
Jeffrey R. Strawn,, MDPrincipal Investigator
University of Cincinnati
Laura B. Ramsey, PhDPrincipal Investigator
Children's Hospital Medical Center, Cincinnati

Media Library

Escitalopram (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04623099 — Phase 4
Anxiety Research Study Groups: Standard dosing, Pharmacogenetically-guided escitalopram dosing
Anxiety Clinical Trial 2023: Escitalopram Highlights & Side Effects. Trial Name: NCT04623099 — Phase 4
Escitalopram (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04623099 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions within this investigation for participants?

"Affirmative. indicates that the trial, which was initially advertised on March 8th 2021, is currently enrolling participants. 132 individuals from 1 clinical site are being sought for this research program."

Answered by AI

To what extent could Escitalopram be detrimental to individuals?

"Based on the Phase 4 status of Escitalopram, our team at Power assigned a score of 3 to its safety rating. This drug has already been approved for patient use."

Answered by AI

What is the upper limit of individuals participating in this clinical experiment?

"Affirmative. informs that recruitment for this medical experiment is ongoing, commencing on the 8th of March 2021 and last updated on the 14th February 2022. In total, 132 individuals are required to participate at a single site."

Answered by AI

What qualifications do potential participants need to meet in order to be eligible for this experiment?

"This clinical trial calls for 132 participants, aged between 12 and 17 years old and suffering from an anxiety disorder."

Answered by AI

Are there any prior research studies that have explored the effects of Escitalopram?

"Presently, 23 different clinical trials are researching escitalopram with 5 of those in the final stages. Most of these tests take place in Cincinnati, Ohio though there are 45 distinct sites running this investigation."

Answered by AI

Does this trial encompass participants aged 85 and over?

"This study is open to adolescents aged 12-17. has 148 trials recruiting for individuals under 18 and 453 studies looking for participants over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
What portion of applicants met pre-screening criteria?
Met criteria
~52 spots leftby Jun 2025